Virtual Reality; the Effect on Pain Reduction During an External Version.

Not Applicable

Completed

• Conditions: Pain
• Interventions: Device: Virtual reality intervention performed through the Oculuc Go VR glasses

• Registration Number: NCT05742971
• Lead Sponsor: Zuyderland Medisch Centrum

Brief Summary

SUMMARY

Rationale: The use of an external cephalic version (ECV) to rotate the fetus from a non-cephalic to cephalic presentation reduces the rate of caesarean section by approximately two-thirds in term pregnancies with breech presentation. Reducing pain during external cephalic version can contribute to an increase in success rate and consequently reduce the number of cesarean sections. Literature about the effectivity of virtual reality (VR) on acute pain reduction seems promising.

Objective: The primary objective of this study is to explore the effect of VR on pain during ECV. Secondary objectives are the rate of successful ECV procedures and to explore tolerability, feasibility and patient satisfaction of VR use.

Study design: The study concerns a non-blinded, single centre, randomised controlled trial.

Study population: Eligible women who fulfill the inclusion criteria and are scheduled for an external cephalic version in the Zuyderland Medical Centre location Heerlen.

Intervention: The study population will be randomly divided into the intervention group (VR-group) or the standard care group. The intervention group can choose for an immersive guided relaxation VR experience or an interactive VR experience during the external version additional to the usual standard care. The participants randomised to the standard care group receive the usual standard care given during external version.

Main study parameters/endpoints: The primary outcome is pain measured on a numeric rating scale (NRS). A total of 42 patients have to be included in each group. This means that a total of 84 women will have to be included in the study.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Each participating woman is asked to complete a questionnaire after using VR and the degree of pain perception is questioned on the basis of a 0-10 score (NRS). The study population experiences a very small medical risk when participating to this study. They can experience side-effects of VR for example dizziness or nausea and in rare cases epileptic insults.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-19
• Status Verified: 2023-02
• Study First Submitted: 2023-02-09
• Study First Submitted QC: 2023-02-22
• Study First Posted: 2023-02-24
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 85

Inclusion Criteria

• Written and orally given informed consent
• 18 years and older
• Native Dutch speaker
• Singleton pregnancy in breech position
• Scheduled ECV

Exclusion Criteria

• Contraindication for ECV
• Chronic pain patients defined as 'persistent or recurrent pain lasting longer than 3 months' [16]. The pain is not due to an obstetrical problem.
• Chronic use of pain medication (opioids)
• Alcohol or drug abuse
• Known car sickness
• Epileptic insults in previous history
• Psychotically seizures in previous history
• Claustrophobic
• Blindness
• History of mental illness
• Patients in strict isolation (MRSA)
• Age <18 years
• Twin pregnancy
• No native Dutch speaker

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VR group	Virtual reality intervention performed through the Oculuc Go VR glasses	The intervention group can choose for an immersive guided relaxation VR experience or an interactive VR experience during the external version Immediately after the external version, a pain measurement is taken with regard to the pain during the ECV by means of the NRS score. After the ECV procedure, participants of the VR-group receive a structured questionnaire in which tolerability, feasibility and satisfaction of VR use is evaluated.

Primary Outcome Measures

Name	Time	Method
Change of pain during ECV when using VR (VAS, visual analogue scale)	15 minutes	pain score by VAS visual analogue scale minimum 0-maximum 10 (higher score is a worse outcome).

Secondary Outcome Measures

Name	Time	Method
Rate of successful ECV procedures	15 minutes
Patient tolerability, feasibility and satisfaction of VR use (questionnaire)	15 minutes

Trial Locations

Locations (1)

Zuyderaland MC; 🇳🇱 Heerlen, Netherlands